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| Sponsored by: |
Technische Universität München |
|---|---|
| Information provided by: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT00408941 |
Purpose
The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Propofol Drug: Prilocaine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | EEG and Auditory Evoked Potentials During Local Anesthesia |
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2006 |
Spontaneous or evoked electrical brain activity is increasingly used to monitor general anesthesia. During alertness, surgery and anesthesia the quality of AEP recordings may be reduced by artefacts. This poses the question to what extent AEP are sensitive for muscular artefacts. High frequency artefacts can have its seeds in muscles and in technical instruments in the operating room. Therefore, the study will take place under the terms of laboratory.
The present study was designed to measure the influence of muscular artefacts on AEP under propofol sedation with or without local anesthesia in the area of the electrodes.
If artefacts influence AEP, which are used to measure anesthesia, it is particularly interesting with regard to clinical application. AEP as a measure of "anesthetic depth" may not only reflect brain, but also muscular and high frequency activity. Therefore, while using muscle relaxants, the AEP of an awake patient may indicate deep anesthesia, because muscle signals are absent.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gerhard Schneider, MD | +49 89 4140 4291 | gerhard.schneider@lrz.tum.de |
| Contact: Sabine Paprotny, MD | +49 89 4140 4291 | s_paprotny@web.de |
| Germany, Bavaria | |
| Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology | |
| Munich, Bavaria, Germany, 81675 | |
| Study Chair: | Eberhard Kochs, MD | Klinikum rechts der Isar der Technischen Universität München |
More Information
| Study ID Numbers: | 1505/06 |
| Study First Received: | December 7, 2006 |
| Last Updated: | December 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00408941 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
EEG AEP Artefacts Propofol Local Anaesthesia |
|
Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives Prilocaine Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Healthy Propofol Anesthetics, Local |
|
Anesthetics, Intravenous Prilocaine Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Anesthetics, Local |
Sensory System Agents Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Propofol Central Nervous System Agents |
